GUEST COLUMNISTS

• 9 Common Tech Transfer Pitfalls To Avoid

  Many issues can trip up a tech transfer process. Here are nine of them— plus ways to mitigate each one.

• Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation

  In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.

• Uncovering Cell Culture Media's Part In Latest Biopharma Trends

  Cell culture media are ubiquitous in just about every bioprocess system, and advanced modalities are putting specialty media in the spotlight.

• Making Good Decisions When FDA Investigators Come Knocking

  Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.

• 5 Recommendations To Maximize CSV/CSA Outcomes

  The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

• How Eli Lilly's Making Peptides Faster And More Reliably

  Three company leaders answer questions about the IE2b project, which is receiving an ISPE 2024 Facility of the Year Award for its ingenuity of complexity.

• Bacterial Endotoxin Testing, Part 1: Overview

  All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

• More Case Studies: Managing Change In Vaccine Production

  Part two of this series digs into real-world examples from Sanofi for getting the right stakeholders on board when altering a process or changing equipment.